KNEE OSTEOARTHRITIS MedDRA version: 14.0 Level: PT Classification code 10031161 Term: Osteoarthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Code: SAR113945
Pharmaceutical Form: Powder for suspension for injection
INN or Proposed INN: SAR113945
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentratio
Sponsors
sanofi-aventis recherche et développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosis of primary knee osteoarthritis, based upon the following: - X-ray or Magnetic Resonance Imaging (MRI) evidence within the last 6 months for joint space narrowing and osteophyte formation - Patients will be Kellgren and Lawrence classification II/III, and total Western Ontario McMaster (WOMAC) score 24 -72. - Patients fulfilling the American College of Rheumatology Clinical and Radiographic criteria for Osteoarthritis. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 77 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 77
Exclusion criteria
Exclusion criteria: - Patients younger than 40 years - Women of child bearing potential. - Women either sterilized for more than 3 months, or post-menopausal for more than 12 months. Menopause is defined as over age of 60 years or being amenorrheic for at least 2 years with plasma FSH level >30 IU/L. - Secondary osteoarthritis: e.g., autoimmune disease, joint dysplasia, aseptic osteonecrosis, acromegaly, Paget’s disease, Ehlers-Danlos Syndrome, Gaucher’s disease, Stickler’s syndrome, joint infection, haemophilia, haemochromatosis, calcium pyrophosphate deposition disease, or neuropathic arthropathy. - Presence of local skin abnormality at the affected knee joint. - Intra-articular injection within 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part 1 TDU11685: assess safety in patients with knee osteoarthritis. Part 2 ACT12505: assess efficacy in patients with knee osteoarthritis ;Secondary Objective: Part 1 TDU11685: tolerability and pharmacokinetics (PK) of single intra-articular doses of SAR113945. Part 2 ACT12505: safety and tolerability of a single intra-articular dose of SAR113945. ;Primary end point(s): Safety: TDU11685/ACT12505 Clinical and standard laboratory investigations: Adverse events (will be recorded from signing of the informed consent up to the study visit at Day 168), physical examination, 12 lead ECGs, vital signs (BP, HR, and body temperature), hematology/coagulation, biochemistry, urinalysis. Specific to the study: •Examination of injected knee: oSkin/soft tissue at injection site –pain, erythema, oedema, haematoma. oJoint –pain, joint effusion, warmth. Efficacy:ACT12505 WOMAC pain, stiffness and physical function sub-scales. The primary endpoint will be the reduction (absolute change from baseline) in WOMAC Pain sub-scale at Day 56.The secondary endpoints will be the reduction (absolute change from baseline) in WOMAC Pain sub-scale at Days 84, 112 and 168 - to evaluate the duration of action of SAR113945, plus analysis WOMAC total score plus other sub-scales. ;Timepoint(s) of evaluation of this end point: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Womac Total Score (24 items) Womac Stiffness (2 items) Womac Physical Function (17 items) Pharmacokinetics (Cmax, AUC, t1/2 and synovial fluid levels) Adverse Events of sepcial interest: tolerability at the site of injection and in the knee + other events reported by the patient;Timepoint(s) of evaluation of this end point: at 8, 12 and 24 weeks at 8, 12 and 24 weeks at 8, 12 and 24 weeks during 24 weeks during 24 weeks | — |
Countries
Germany
Outcome results
None listed